A Phase 1b, Single-arm, Open-label Clinical Trial to Evaluate Corrected QT Interval and Drug-drug Interaction of Traztuzumab on Carboplatin in the Presence of Docetaxel in Patients With Metastatic Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Cancers
Both
Solid Cancers
Trial Information
A Phase 1b, Single-arm, Open-label Clinical Trial to Evaluate Corrected QT Interval and Drug-drug Interaction of Traztuzumab on Carboplatin in the Presence of Docetaxel in Patients With Metastatic Cancer
Inclusion Criteria:
- Histologic documentation of a HER2-positive solid malignancy in patients with
metastatic or locally advanced inoperable disease
- Left ventricular ejection fraction (LVEF) >/= 50% by multiple-gated acquisition
(MUGA) scan or two-dimensional echocardiography (ECHO) Day 1
Exclusion Criteria:
- History of trastuzumab treatment
- Pretreatment QTcF interval > 450 ms as determined by local assessment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
QTcF interval
Outcome Time Frame:
At each postbaseline timepoint
Safety Issue:
No
Principal Investigator
Harald Weber, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
H4613g
NCT ID:
NCT00927589
Start Date:
July 2009
Completion Date:
February 2013
Related Keywords:
- Solid Cancers
- HER2+ Locally Advanced Inoperable Cancer
- HER2+ Metastatic Cancer
- HER2+ Solid Malignancy
- Neoplasm Metastasis
Name | Location |
|---|---|
| Great Falls, Montana 59405 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Kansas City, Kansas 66160 | |
| Albuquerque, New Mexico 87131-5636 |
